A Study of Nab-Paclitaxel and Gemcitabine With or Without Olaratumab (LY3012207) in Participants With Metastatic Pancreatic Cancer

• Status: Active, not recruiting
• Trial end date: 2021-11-16
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and efficacy of nab-paclitaxel and gemcitabine with or without olaratumab in the treatment of first-line metastatic pancreatic cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Olaratumab; Paclitaxel

Criteria

Inclusion Criteria:

• Histological or cytological diagnosis of adenocarcinoma of the exocrine pancreas that is metastatic (Stage IV) and not amenable to resection with curative intent.

• If present, clinically significant or symptomatic amounts of ascites should be drained prior to Day 1.

• Have had no prior systemic treatment for metastatic disease. Prior adjuvant or neo-adjuvant chemotherapy or radiochemotherapy (other than nab-paclitaxel) is allowed if completed ≥3 months prior to enrollment and no lingering toxicities are present.

• Prior radiation therapy for treatment of cancer is allowed to <25% of the bone marrow.

• Phase 2: archival tumor tissue or be willing to provide a pre-treatment biopsy.

• Measurable or nonmeasurable but evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

• Discontinued all previous treatments for cancer ≥4 weeks prior.

• Adequate organ function.

• Life expectancy of at least 3 months.

Exclusion Criteria:

• Serious concomitant systemic disorder.

• Have received first line treatment for metastatic pancreatic cancer.

• Received prior treatment with nab-paclitaxel.

• Have known central nervous system malignancy or metastasis.

• Current hematologic malignancies.

• Participated within the last 30 days in a clinical trial involving an investigational product.

• Women with a positive pregnancy test or lactating.

• Have endocrine pancreatic tumors or ampullary cancer.

• Currently enrolled in another clinical trial.

• Have a known additional malignancy that is progressing or required active treatment within the past 1 year.

• Known allergy to nab-paclitaxel or gemcitabine or any ingredient of study drug formulations.

• Are taking certain anti-coagulant medications such as warfarin and are unable to be switched to other similar medicines.